Molly M. Cone

Utilization of laparoscopic colectomy in the United States before and after the clinical outcomes of surgical therapy study group trial.

Objective: To evaluate the utilization of laparoscopic colectomy (LC) in the United States before and after prospective data supported its use for the treatment of colon cancer. Methods: The Nationwide Inpatient Sample 2001–2003 [before Clinical Outcomes of Surgical Therapy (COST)] and 2005–2007 (after COST) was queried for elective colectomies for both benign and malignant disease. The COST trial was published in 2004; therefore, 2004 data were excluded. Univariate analyses including patient-specific, hospital-specific, and outcome variables were performed. Multivariate logistic regression models and subset analyses were used to evaluate these variables and operative approach by time frame. Results: The query yielded 741,817 elective colectomies (684,969 open and 56,848 laparoscopic). The percentage of elective colectomies performed laparoscopically has increased over time. Laparoscopic colectomy for benign disease increased from 6.2% in 2001–2003 to 11.8% in 2005–2007, while those for colon cancer have increased by a larger percentage, 2.3% to 8.9%. In a multivariate model of patients with colon cancer, the odds ratio (OR) for having a laparoscopic approach after COST was 4.55 (confidence interval 3.81–5.44) compared with before COST. In contrast, for benign disease, the OR was 2.10 (confidence interval 1.79–2.46). Factors predictive of having a laparoscopic approach for cancer have changed very little over time: Patients are more likely to be male, insured, live in areas with the highest incomes, and undergo resection at urban teaching hospitals. Conclusions: Within 3 years after publication of the COST trial, the use of laparoscopic resection for colon cancer approached that of benign disease. However, almost 90% of cases are still performed open and utilization remains influenced by socioeconomic factors.

Dramatic decreases in mortality from laparoscopic colon resections based on data from the Nationwide Inpatient Sample.

OBJECTIVE To determine the mortality rate and associated factors for laparoscopic and open colectomy as derived from the Nationwide Inpatient Sample database. DESIGN Retrospective cohort. SETTING Nationwide Inpatient Sample database. PATIENTS Between 2002 and 2007, the Nationwide Inpatient Sample estimated 1,314,696 patients underwent colectomy in the United States. Most (n = 1,231,184) were open, but 83,512 were laparoscopic. Patients who underwent a laparoscopic procedure that was converted to open were analyzed within the laparoscopic group on an intention-to-treat basis. MAIN OUTCOME MEASURE Mortality rate. Using a logistic regression model, patient and institutional characteristics were analyzed and evaluated for significant associations with in-hospital mortality. RESULTS In a multivariate analysis, significant predictors of increased mortality included older age, male sex, lower socioeconomic status, comorbidities, and emergency or transfer admission. Additionally, a laparoscopic approach was an independent predictor of decreased mortality when compared with open colectomy (relative risk, 0.51; P < .001). CONCLUSION Even when controlling for comorbidities, socioeconomic status, practice setting, and admission type, laparoscopy is an independent predictor of decreased mortality for colon resection.

Laparoscopic converted to open colectomy: predictors and outcomes from the Nationwide Inpatient Sample.

BACKGROUND Early in their learning curve, surgeons need to appropriately select patients to avoid conversion from laparoscopic to an open colectomy. METHODS Using the Nationwide Inpatient Sample, laparoscopic and laparoscopic converted to open colectomies performed between 2002 and 2007 were compared. We evaluated patient and institutional characteristics to find significant predictors and outcomes of conversion. RESULTS Between 2002 and 2007, the rate of conversion was high, ranging from 35.7% to 38.0%. Multivariate predictors of conversion included obesity, diverticulitis, inflammatory bowel disease, constipation, metastatic disease, nonelective admission, left or transverse colectomy, intraoperative complication, lower socioeconomic status, uninsured status, and rural hospital location. A colectomy for benign colon polyps was less likely to be converted. Conversion to an open colectomy did not increase inpatient mortality. CONCLUSIONS Predictors of conversion from open to laparoscopic colectomy were found from a national database reflecting all US laparoscopic colectomies. Conversion did not increase inpatient mortality.

Effect of surgical approach on 30-day mortality and morbidity after elective colectomy: a NSQIP study.

PurposeThe aim of this study was to evaluate the laparoscopic approach and pre- and postoperative conditions as predictors of 30-day mortality and morbidity in elective colectomy.MethodsElective colectomies were identified in the 2005–2008 American College of Surgeons National Surgical Quality Improvement Program database. Multivariate logistic regression was used to model 30-day mortality and morbidity following elective colectomy. Propensity scores were calculated to decrease selection bias.ResultsDuring the period studied, 14,321 patients underwent open colectomy and 10,409 underwent laparoscopic colectomy. Factors that significantly influenced mortality included male gender [odds ratio (OR) 1.4, confidence interval (CI) 1.07–1.9]; age (OR 1.07, CI 1.05–1.08); comorbidities including dyspnea, ascites, congestive heart failure, dialysis, or disseminated cancer; and postoperative conditions including reintubation (OR 2.6, CI 1.6–4.0), renal failure (OR 3.8, CI 2.1–6.9), stroke (OR 6.44, CI 2.4–17.6), and septic shock (OR 13.1, CI 8.76–19.4). While laparoscopy was not independently associated with mortality, it was associated with decreased postoperative morbidity including reintubation (OR 0.74, CI 0.59–0.91), renal failure (OR 0.60, CI 0.4–0.91), septic shock (OR 0.74, CI 0.59–0.92), wound infection (OR 0.58, CI0.44–0.77), and pneumonia (OR 0.71, CI 0.59–0.86).ConclusionsBased on this analysis, laparoscopy was associated with a decrease in 30-day postoperative morbidity for colectomy. However, after adjusting for preoperative comorbidities and postoperative morbidities, laparoscopy did not independently influence mortality after colectomy.

Disparities in the treatment of colon cancer in octogenarians

BACKGROUND Disparities in healthcare for the elderly are understudied, despite the increasing proportion of patients over 80 years of age. Advanced age is a principal risk factor for colorectal adenocarcinoma, but there are few data to guide treatment in the elderly patient population. METHODS We performed a retrospective review of prospectively gathered data on 10,433 patients diagnosed with primary colon tumors between 1998 and 2004. We compared demographics, stage at diagnosis, and initial treatment between patients younger than 80 years and those age 80 years or older. RESULTS Patients who were >or=80 years old made up 30% of the database. Older patients were less likely to have colectomy for advanced or metastatic disease than younger patients. Patients who were >or=80 years of age had fewer lymph nodes removed than younger patients (11 vs 10, P <.01). Older patients were significantly less likely to receive chemotherapy for every stage of colon cancer than younger patients. When older patients did get chemotherapy, it was more likely to be with a single agent. Multivariate analysis revealed that predictors of receiving chemotherapy for patients >or=80 years of age include living in an urban county, younger age, and worse stage at diagnosis. CONCLUSIONS Older patients make up a large portion of the patients treated for colon cancer and are treated less aggressively. While some of the treatment difference may be explained by medical factors, demographic factors affect treatment decisions as well.

Predicting malignant intraductal papillary mucinous neoplasm: a single-center review.

BACKGROUND The purpose of this study was to examine the characteristics of pancreatic intraductal papillary mucinous neoplasm (IPMN) in our institution and the selection for resection. Recent publications, including those from the International Consensus Guidelines and the Mayo Clinic, set forth criteria for resection. However, these criteria differ in the definition of main duct IPMN, which is an indication to resect. METHODS Sixty patients from a single institution were retrospectively reviewed between 2000 and 2009. RESULTS Thirteen percent of patients had high-grade dysplasia, and 22% had invasive cancer. In multivariate analysis, factors associated with a lower risk of carcinoma were female sex (P = .039) and size <3 cm (P = .024). Patients were retrospectively evaluated with Mayo and International Consensus Guidelines. Eight patients had a diagnosis that would have changed from main duct to branch duct if the International Consensus Guidelines were used. Of these 8, there were 2 cancers. If the International Consensus Guidelines were applied instead of the Mayo, both cancers would have been resected, but 2 patients without cancer would have been spared an operation. CONCLUSIONS Twenty-two percent of resected patients had invasive cancer, and they had significantly worse survival (37 vs 85 months, P = .032). In our patient group, application of the International Consensus Guidelines identified all malignant IPMN and would have prevented 2 nontherapeutic resections when compared with the Mayo criteria.

Use and outcomes of emergent laparoscopic resection for acute diverticulitis

BACKGROUND The use and outcomes of laparoscopic sigmoid resection during emergency admissions for diverticulitis are unknown. METHODS The Nationwide Inpatient Sample was queried for colorectal resections performed for diverticulitis during emergent hospital admissions (2003-2007). Univariate and multivariate analyses including patient, hospital, and outcome variables were performed. RESULTS A national estimate of 67,645 resections (4% laparoscopic) was evaluated. The rate of conversion to open operation was 55%. Ostomies were created in 66% of patients, 67% open and 41% laparoscopic. Laparoscopy was not a predictor of mortality (odds ratio [OR] =.70; confidence interval [CI], .32-1.53). Laparoscopy predicted routine discharge (OR = 1.31; CI, 1.06-1.63) and a decreased length of stay (absolute days = -.78; CI, -1.19 to -.37). There was no difference in the cost of hospitalization between the 2 groups (P = .45). CONCLUSIONS In acute diverticulitis, urgent laparoscopic resection decreases the length of stay. However, it is associated with a high conversion rate, no cost savings, and no difference in mortality.

Endoscopic ultrasound may be unnecessary in the preoperative evaluation of intraductal papillary mucinous neoplasm

OBJECTIVES Several imaging modalities are commonly performed during work-up of intraductal papillary mucinous neoplasm (IPMN), but guidelines do not suggest any one technique. The aim of this study was to evaluate tumour and duct measurements by computed tomography (CT) and endoscopic ultrasound (EUS) and their ability to predict high-grade dysplasia (HGD) and cancer within pancreatic IPMN. METHODS Patients with IPMN who underwent preoperative CT and EUS between 2001 and 2009 were selected. Data were gathered retrospectively from medical records. RESULTS The study group was comprised of 52 patients, 33% (17/52) of whom had HGD or cancer. On fine needle aspirate (FNA), neither carcinoembryonic antigen (CEA) >200 nor cytological analysis correlated with malignancy. In multivariate analysis, duct size ≥ 1.0 cm (P= 0.034) was a significant predictor of HGD or cancer, and diameter on CT scan (P= 0.056) approached significance. Lesion diameter of ≥ 2.5 cm on CT scan identified malignancy in 71% (12/17) of patients (P= 0.037). When analysed, all patients with HGD or cancer had a lesion diameter ≥ 2.5 cm and/or a duct diameter ≥ 1.0 cm by CT scan. CONCLUSIONS The use of radiographic criteria on CT including lesion size ≥ 2.5 cm and/or pancreatic duct diameter ≥ 1.0 cm appears to reliably identify patients with either HGD or invasive cancer. High-resolution CT scanning may obviate the need for EUS and FNA in patients with suspected IPMN.

Ethnicity influences lymph node resection in colon cancer.

The purpose of this study is to determine the association between ethnicity and lymph node retrieval after colon cancer resection. Using the Surveillance Epidemiology and End Results (SEER)–Medicare database, patients who underwent colon cancer resection from 2000–2003 were evaluated. Subjects were classified as having <12 (N = 20,605) or ≥12 (N = 12,358) lymph nodes examined. Multivariate models were used to analyze the relationship between lymph nodes resected and independent variables. Out of a total of 32,936 patients, 62.5% had fewer than 12 lymph nodes resected. In multivariate analysis, Hispanic ethnicity was associated with a significantly lower chance of having ≥12 lymph nodes than the Caucasian population (OR = 0.61; CI, 0.50–0.74). Despite this, there was no understaging: the proportion of stage II and III diagnoses was the same. Both groups received the same rate of cancer-directed surgery and survival was equivalent. During this study period, a majority of colon cancer resections were inadequate based on the current standard of ≥12 nodes. Hispanic patients were less likely to have an adequate node resection when compared to Caucasians. Despite fewer lymph nodes harvested, they had equivalent staging and survival. These results suggest that ethnicity influences the lymph node count.

Sa1263 A Prospective Multicenter Trial Evaluating the Benefit of Initial Seton Placement Prior to Starting Anti-TNF Therapy for the Treatment of Crohn's Perianal Fistulas

Background Fistulizing disease occurs in up to 40% of patients with Crohns disease (CD) . Symptoms, including anal pain, purulent discharge, and incontinence, are associated with high morbidity and impaired quality of life. Vedolizumab (VDZ) is a monoclonal antibody to alpha4beta7 integrin with demonstrated efficacy and safety in the treatment of patients with CD. The present exploratory analysis evaluated the efficacy of VDZ in the subpopulation of patients with fistulizing CD from a phase 3, randomized, placebo (PBO)-controlled trial (GEMINI 2).1 Methods In the GEMINI 2 study, patients who received 2 doses of VDZ during the induction phase and achieved a clinical response at week 6 received treatment with PBO or VDZ 300 mg every 8 weeks (Q8W) or every 4 weeks (Q4W) for an additional 46 weeks (maintenance intent-to-treat [ITT] population). Fistula closure, a prespecified exploratory endpoint, was assessed at each visit (2-6 week intervals) until week 52. The percentage of patients achieving fistula closure and mean time to fistula closure were calculated. Results Among the maintenance ITT population (N=461), 57 patients (12%) had 1 or more draining fistulae at study entry, with 74% of fistulae located perianally. Of these patients, 44-49% had failed prior anti-tumor necrosis factor therapy and 39-54% had prior surgery for CD. By week 14, 28% of patients treated with VDZ/VDZ (Q8W + Q4W combined) had achieved fistula closure versus 11% of those receiving VDZ/PBO (Table). This treatment difference was maintained up to week 52. Kaplan-Meier probabilities of fistula closure with VDZ treatment were 29.2% and 33.4% at 6 and 12 months, respectively; notably, the number of patients at risk was small (Figure). Conclusion In the GEMINI 2 maintenance ITT population, a greater percentage of patients with draining fistulae at study entry achieved fistula closure when they continued treatment with VDZ compared with those who were re-randomized to PBO. This effect was maintained through to week 52.These preliminary findings support the role of VDZ in the treatment of fistulizing disease and warrant further investigation in dedicated prospective studies in this population. Reference 1. Sandborn WJ, et al. N Engl J Med . 2013;369(8):711-721; NCT00783692. The clinical study was funded by Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.). Medical writing assistance was provided by inVentiv Medical Communications and supported by Takeda Pharmaceuticals International, Inc.